Lumvoa Approved for Thyroid Eye Disease
On June 26, 2026, the US Food and Drug Administration (FDA) approved Viridian Therapeutics’ Lumvoa™ (veligrotug-vvze) for the treatment of thyroid eye disease (TED), regardless of disease activity or duration. Lumvoa is a full antagonist of the insulin-like growth factor-1 receptor (IGF-1R). The labeling includes data in both active and chronic disease, including statistically significant improvements in diplopia (double vision) response and complete diplopia resolution. Lumvoa is administered as five intravenous (IV) infusions given every three weeks over a 12-week treatment course over 30-45 minutes. The prescribing information for Lumvoa includes warnings and precautions for infusion reactions, inflammatory bowel disease, hyperglycemia, and hearing impairment, including cases of potentially permanent hearing loss. Viridian announced an immediate launch following approval. Cost information was not disclosed. Full prescribing information can be found here.
At a Glance
- Brand Drug: Lumvoa™ (veligrotug-vvze)
- Manufacturer: Viridian Therapeutics
- Date Approved: June 26, 2026
- Indication: For the treatment of thyroid eye disease regardless of thyroid eye disease activity or duration
- Dosage Forms Available: 500mg/10mL solution in a single-dose vial
- Launch Date: Immediately
- Estimated Annual Cost: Not yet announced.
- FDA Designation: Breakthrough Therapy. Priority Review.
- TED, also known as Graves’ ophthalmopathy or orbitopathy, is an autoimmune disease characterized by inflammation and tissue remodeling around and behind the eyes. As a result, the eyes develop a characteristic protrusion known as proptosis. Patients who have TED also may experience swollen eyelids, irritated eyes, light sensitivity, and double or blurred vision.
- Approximately 40% of individuals who have Graves’ disease develop TED, affecting an estimated 1 million people in the US.
- Approval was supported by the phase III THRIVE (active TED) and THRIVE-2 (chronic TED) trials, in which Lumvoa demonstrated rapid and clinically meaningful improvements across key signs and symptoms of TED, including a statistically significant 48% proptosis responder rate in chronic disease and sustained benefit through 52 weeks in 70% of initial responders. It also demonstrated a rapid onset of clinical benefit, with reductions in proptosis observed as early as three weeks.
- Lumvoa was generally well tolerated across both trials, with most adverse events being mild or transient, although hearing impairment was reported more frequently in treated patients than with placebo.
- Lumvoa represents a new competitor to Amgen’s Tepezza® (teprotumumab), the only previously approved IGF-1R–targeting therapy for TED. It is administered as an IV infusion every three weeks for eight infusions over 60-90 minutes.
- There are additional TED treatments in the pipeline, including Amgen’s subcutaneous (SC) Tepezza administered via an on-body injector, which demonstrated comparable performance to IV administration in a phase III study, and Viridian’s SC anti-IGF-1R therapy, elegrobart, which achieved positive phase III results and is targeted for a biologics license application submission in Q1 2027.